A Study to Evaluate the Efficacy and Safety of Combination Treatment of Fimasartan/Atorvastatin in Patients With Essential Hypertension and Dyslipidemia

Phase 3

Completed

• Conditions: Essential Hypertension, Dyslipidemia
• Interventions: Drug: Atorvastatin 40mg; Drug: Fimasartan 120mg; Drug: Placebo for Atorvastatin 40mg; Drug: Placebo for Fimasartan 120mg

• Registration Number: NCT03338426
• Lead Sponsor: Boryung Pharmaceutical Co., Ltd

Brief Summary

The objective of this clinical study is to evaluate the efficacy and safety by comparing the fimasartan/atorvastatin treatment group to the fimasartan/placebo treatment group and the placebo/atorvastatin treatment group respectively at Week 8 in patients with essential hypertension and dyslipidemia.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-10-30
• Study First Submitted QC: 2017-11-06
• Study First Posted: 2017-11-09
• Study Start: 2018-01-15
• Primary Completion: 2019-04-22
• Study Completion: 2019-04-22
• Status Verified: 2019-10
• Last Update Submitted: 2019-11-04
• Last Update Posted: 2019-11-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 133

Inclusion Criteria

1. Voluntarily provided a written consent to participate in this clinical study
2. Male or female adults aged 19-70 years
3. Patients must have been confirmed essential hypertension and dyslipidemia at Screening visit (V1)
4. Uncontrolled blood pressure (140 mmHg ≤ mean SiSBP < 180 mmHg) at the pre- baseline visit (V2) after wash-out period
5. Able to understand this study, be cooperative in the execution of the study, and participate in the study until its completion

Exclusion Criteria

1. Severe hypertension with mean Sitting systolic blood pressure(SiSBP)≥180 mmHg or Sitting diastolic blood pressure(SiDBP) ≥110 mmHg at the screening visit (V1) and the pre-baseline visit (V2), or orthostatic hypotension accompanied by symptoms
2. Difference of Sitting systolic blood pressure(SiSBP) ≥ 20 mmHg and Sitting diastolic blood pressure(SiDBP) ≥ 10 mmHg between Lt and Rt arms for 3 consecutive times at the screening visit (V1)
3. Secondary hypertension patients: Secondary hypertension is not limited to the following diseases; (e.g., renovascular disease, adrenal medullary and cortical hyperfunctions, coarctation of the aorta, hyperaldosteronism, unilateral or bilateral renal artery stenosis, Cushing's syndrome, pheochromocytoma, and polycystic kidney disease)
4. Uncontrolled diabetes mellitus (currently on insulin, or HbA1c >9% at the pre-baseline visit (V2)), or uncontrolled hypothyroidism (TSH ≥1.5 times the upper limit at the pre-baseline visit (V2))
5. Heart disease (heart failure of New York Heart Association (NYHA) class 3 and 4), or ischemic heart disease (angina pectoris, myocardial infarction), peripheral vascular diseasenewly diagnosed within 6 months prior to the screening visit (V1), percutaneous transluminal coronary angioplasty, or coronary artery bypass graft, etc.
6. Clinically significant ventricular tachycardia, atrial fibrillation, atrial flutter; or other arrhythmia conditions that are determined to be clinically significant by the investigator
7. Hypertrophic obstructive cardiomyopathy, severe obstructive coronary artery disease, aortic stenosis, or hemodynamically significant aortic valve stenosis or mitral valve stenosis
8. Cerebrovascular disorder (stroke, cerebral infarction, transient cerebral ischemic attack, cerebral hemorrhage, etc. within 6 months prior to the screening visit (V1)
9. Pregnant or lactating women

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active Comparator 2	Atorvastatin 40mg	Co-administration of Atorvastatin 40mg and Placebo for Fimasartan 120mg
Experimental	Atorvastatin 40mg	Co-administration of a fixed dose combination of Fimasartan 120mg and Atorvastatin 40mg
Active Comparator 1	Fimasartan 120mg	Co-administration of Fimasartan 120mg and Placebo for Atorvastatin 40mg
Active Comparator 1	Placebo for Atorvastatin 40mg	Co-administration of Fimasartan 120mg and Placebo for Atorvastatin 40mg
Experimental	Fimasartan 120mg	Co-administration of a fixed dose combination of Fimasartan 120mg and Atorvastatin 40mg
Active Comparator 2	Placebo for Fimasartan 120mg	Co-administration of Atorvastatin 40mg and Placebo for Fimasartan 120mg

Primary Outcome Measures

Name	Time	Method
LDL-C	8weeks from Baseline Visit	The change in LDL-C from baseline in the test group at Week 8 compared to the active comparator group 1(fimasartan 120 mg)
SiSBP	8weeks from Baseline Visit	The change in Sitting systolic blood pressure(SiSBP) from baseline in the test group(Fimasartan 120mg/Atorvastatin 40mg) at Week 8 compared to the Active Comparator group 2(Atorvastatin 40mg)

Secondary Outcome Measures

Name	Time	Method
LDL-C	8weeks from Baseline Visit	The change in LDL-C from baseline in the test group(Fimasartan 120mg/Atorvastatin 40mg) at Week 8 compared to the Active Comparator group 2(Atorvastatin 40mg)
SiSBP	8weeks from Baseline Visit	The change in Sitting systolic blood pressure(SiSBP) from baseline in the test group(Fimasartan 120mg/Atorvastatin 40mg) at Week 8 compared to the Active Comparator group 1(Fimasartan 120mg)

Trial Locations

Locations (1)

Severance Hospital; 🇰🇷 Seoul, Korea, Republic of